JMIR Publications

ABSTRACT

The current study is a single-arm, open-label, controlled, quasi-drug trial that was conducted under the crossover design. Subjects who submitted a written informed consent and were eligible for study participation and then given a crossover allocation of either a comparator or a trial drug. A crossover design is commonly characterized by a wash-out period for the removal of residual effects following randomization (application of a comparator and a trial drug. A total of 68 subjects were evaluated on screening test, whose mean age was 28.91 years old, mean height was 160.93 cm and mean weight was 57.82 kg. Moreover, following an analysis of smoking history, there were 57 never smokers (83.82%), 6 current smokers (8.82%) and 5 former smokers (7.35%). Furthermore, following an analysis of drinking history, there were 2 never drinkers (2.94%), 66 current drinkers (97.06%) and no former drinkers. The degree of overall satisfaction after the use of a menstrual cup was the highest in a question 7. Is a quasi-drug effective in increasing the degree of convenience in terms of “the decreased amount of waste products (e.g., environmental protection)”?. This showed a mean degree of overall satisfaction of 9.31 ± 0.95. To the same question after the use of a tampon, it was measured as 5.75 ± 2.42. In addition, the degree of overall satisfaction was the lowest after the use of a menstrual cup was the lowest in a question 3. Is a quasi-drug effective in increasing the degree of convenience in terms of “the methods of use”?. This showed a mean degree of overall satisfaction of 6.8 ± 1.76. To the same question after the use of a tampon, it was measured as 7.12 ± 1.8. On the other hand, the degree of overall satisfaction after the use of a tampon was the highest in a question 2. Is a quasi-drug effective in increasing the degree of convenience in terms of “the occurrence of daily activities”?. This showed a mean degree of overall satisfaction of 7.78 ± 2.07. To the same question after the use of a menstrual cup, it was measured as 8.42 ± 1.72. In addition, the degree of overall satisfaction after the use of a tampon was the lowest in a question 6. Is a quasi-drug effective in increasing the degree of convenience in terms of “cost-effectiveness (e.g., price of a product)”?. This showed a mean degree of overall satisfaction of 5.53 ± 2 To the same question after the use of a menstrual cup, it was measured as 8.78 ± 1.19. There were a total of 2 cases of adverse events; 1 case of Vulvovaginal candidiasis whose causal relationship with a menstrual cup was demonstrated and another case of vaginal infection that cannot be evaluated. In the safety analysis set, vaginal infection occurred at incidences of 1.59% (1 case) and 0% (0 cases) in association with a menstrual cup and a tampon, respectively. As described above, vaginal infection occurred at incidences of 1.59% (1 case) and 0% (0 cases) in association with a menstrual cup and a tampon, respectively, for which it is impossible to perform statistical analysis. There were no cases of adverse events that are associated with UTI. In conclusion, the current comparative clinical trial showed that a menstrual cup had a higher degree of efficacy and safety based on convenience of use as compared with a tampon.